The lawsuits will be overseen by U.S. District Judge Brian R. Martinotti in the District of New Jersey — In RE: Invokana (Canagliflozin) Products Liability Litigation — Multi-District Litigation (MDL No. 2750).
Judges created the MDL to improve efficiency and help lawyers coordinate testimony, trials, and settlement negotiations. Unlike a class action, each lawsuit remains independent.
All of the lawsuits involve canagliflozin, a new medication for adults with type-2 diabetes. It helps control blood-sugar levels by forcing the kidneys to remove more sugar from the body in urine.
Invokana was the first medication to work this way when it hit the market in 2013. Lawyers accuse Janssen of rushing Invokana to market, inadequately testing it for safety, and failing to warn about side effects.
The FDA has issued several warnings for side effects of Invokana and Invokamet — starting in May 2015 with diabetic ketoacidosis, a life-threatening condition that occurs when the blood becomes too acidic.
The FDA recently strengthened warnings about kidney damage, based on reports of patients whose the kidneys suddenly stopped working. Kidney failure often requires dialysis or an organ transplant.
Most of the lawsuits involve kidney damage or ketoacidosis, but the MDL allows cases involving a variety of other injuries.
Janssen Pharmaceuticals is currently conducting 5 studies to investigate the cardiovascular risks of Invokana. In clinical trials, 13 patients on Invokana had a heart attack or stroke, compared to one patient on a placebo, during the first 30 days of treatment.